NCT06770153招募中不适用
Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- radiographical images
研究概览
简要总结
the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
- •Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
- •Patients who have signed the "informed consent" approved by the Ethics Committee.
- •Patients who are aged between 50-85.
排除标准
- •Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
- •Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
- •Patients with a history of erysipelas in the lower extremities
- •Patients suffering from neurological or psycho-cognitive disorders
- •Patients suffering from post-traumatic arthrosis
- •Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint
- •Patients with axial knee deformities >15°
- •Pregnant female patients
- •Patients with rheumatic diseases
研究组 & 干预措施
Standard
Active Comparator
干预措施: standard (Procedure)
Tensor
Experimental
干预措施: Tensor (Procedure)
结局指标
主要结局
radiographical images
时间窗: at baseline, after 3 months, after 6 months anfer 12 months
take stress x-rays (150 N) of the knee using TELOS to objectively and reproducibly analyze the lift-off (distance between the prosthetic component femoral and the tibial prosthetic component measured in mm)
次要结局
- Hip-Knee-Anke Angle(at baseline, after 3 months, after 6 months anfer 12 months)
- Visual Analogue Scale(at baseline, after 3 months, after 6 months anfer 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)Liver FibrosisNCT03293953Ente Ospedaliero Ospedali Galliera100
招募中
不适用
Scandinavian Olecranon Research in the ElderlyOlecranon FractureNCT04401462Turku University Hospital68
已完成
不适用
Comparison of Curative Effect Between New Tension Band and Patellar Tension Reduction Band in the Treatment of Lower Pole Fractures of PatellaFollow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image DataNCT04960501Peking University Third Hospital41
已完成
不适用
The Acute Effects of Different Stretching Methods in Individuals With Subacromial Impingement SyndromeSubacromial Impingement SyndromeGlenohumeral Internal Rotation DeficitNCT03246867Dokuz Eylul University69
Unknown
不适用
Elastography in Patients With Idiopathic Inflammatory MyopathiesIdiopathic Inflammatory MyopathiesNCT03897803Benha University80